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Drug Substance (API)
Lupin Manufacturing Solutions is the one-stop partner for your API and CDMO needs
LMS is a leading API manufacturer, supplying to more than 70 countries around the globe. Superior chemistry skills and a commitment to quality and cost-effective manufacturing, supported by our two state-of-the-art and regulatory-approved manufacturing sites, form the bedrock of our API capabilities.
Reliability and Quality:
Adhering to stringent global quality standards.
High Quality API’s:
25+ cost-effective APIs, working with 50+ customers globally
Contract Development and manufacturing:
Not just a CDMO, it’s a pool of seasoned team of CMC, regulatory & manufacturing experts from a vertically integrated company with marketed products in US, Europe, Japan, and ROW.
Environmental, social, and governance (ESG):
Lupin’s S&P Global ESG Score over the last four years has gone up from 17 to 76 and this highlights our effort towards sustainability.
Technological Footprints:
Well diversified technological capabilities to support HPAPI, Fermentation, peptide and oncological platforms.
Cost Effective solutions:
Leveraging our India-based professionals & infrastructure, along with the cost-conscious culture, to provide best-in-class service costs & COGS.
Ethical Practices & Confidentiality:
Sustainability, IP Protection are embedded in our DNA.
Regulatory Compliance:
Our plants are USFDA, EDQM, PMDA, TGA, Health Canada approved. Fantastic track records with regulatory and customer audits.
API PRODUCT LIST
Sr. No. | PRODUCT NAME | THERAPEUTIC CATEGORY | REGULATORY FILINGS |
1. | APREMILAST FORM-B/-M | Immunosuppressant | USDMF, CDMF* |
2. | AZILSARTAN KAMEDOXOMIL | Anti-Hypertensive | USDMF, CDMF |
3. | CANNABIDIOL | Anti-Epileptic | USDMF |
4. | CYSTEAMINE BITARTARTE | Neuropathic Cystinosis | USDMF |
5. | DAPAGLIFLOZIN PROPANEDIOL | Anti-Diabetic | TGA, EDMF* |
6. | DAPAGLIFLOZIN PREMIX WITH LACTOSE | Anti-Diabetic | USDMF, KDMF |
7. | DARUNAVIR ETHANOLATE | Anti-Viral | USDMF |
8. | DESVENLAFAXINE SUCCINATE /BENZOATE | Anti-Depressant | USDMF, EUDMF, KDMF |
9. | DEUTERATED TETRABENAZINE | CNS | USDMF |
10. | EMPAGLIFLOZIN CRYSTALLINE | Anti-Diabetic | USDMF, TGA, KDMF |
11. | ESLICARBAZEPINE | Anti-Epileptic | USDMF, EDMF, CEP* |
12. | FERRIC CITRATE | Anti-Hyperphosphatemia | USDMF, Others |
13. | GLYCEROL PHENYL BUTYRATE | Urea Cycle Disorder | USDMF |
14. | IRON SUCROSE | Anti-Anemia | USDMF |
15. | IVACAFTOR | Anti-Cystic fibrosis | USDMF, EUDMF* |
16. | LETERMOVIR | Anti-Retroviral | USDMF, EUDMF* |
17. | LURASIDONE | Anti-Psychotic | USDMF |
18. | MIRABEGRON | Urological | USDMF, CDMF*, CEP* |
19. | MIGALASTAT | Anti-Fabry disease | USDMF, EUDMF* |
20. | PIRFENIDONE | Immunosuppressant | USDMF, CEP, CDMF* |
21. | PIRIBEDIL | Anti-Parkinsons | EUDMF |
22. | RALTEGRAVIR FORM-I/FORM-III | Anti-Retroviral | USDMF, EUDMF, CEP* |
23. | RUFINAMIDE | Anti-Convulsant | USDMF |
24. | SODIUM ZIRCONIUM CYCLOSILICATE | Anti-Hyperkalemia Agent | USDMF, EUDMF* |
25. | SUCROFERRIC OXYHYDROXIDE | Anti-Hyperphosphatemia | USDMF, CDMF* |
26. | TOLVAPTAN | Vasopressin antagonist | USDMF, KDMF |
27. | VALBENAZINE TOSYLATE | CNS | USDMF |
UNDER DEVELOPMENT
Sr. No. | PRODUCT NAME | THERAPEUTIC CATEGORY | SAMPLE |
1. | BEMPEDOIC ACID | Anti-Hyperlipidemia | Available |
2. | BRIVARACETAM | Anti-Epileptic | Under Development |
3. | FERUMOXYTOL | Anti-Anemic | Available |
4. | FERRIC CARBOXY MALTOSE | Anti-Anemic | Available |
5. | RIVAROXABAN | Anti-Coagulant | Under Development |
6. | SITAGLIPTIN PHOSPHATE | Anti-Diabetic | Available |